Kardigan

Kardigan

Sr. Manager, Clinical Trial Lead

Princeton, New Jersey · Senior · Contract

Sponsorship not specified$166k-$216kDetected 26 days ago
GCPVendor ManagementPerformance ManagementClinical TrialsResearchLeadershipCommunicationMentoring

About the role

  • We believe in being authentic -leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted.
  • With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds.
  • These values are the foundation of our work, empowering us to make a real difference, every day.

Responsibilities

  • Lead the planning, execution, and delivery of assigned clinical trials (global or regional scope).
  • Drive study timelines, milestones, and deliverables from synopsis through Clinical Study Report.
  • Partner with CTMs to ensure vendor and site readiness across start-up, enrollment, monitoring, and closeout.
  • In partnership with the COPL, develop and execute participant recruitment strategies; review and approve operational plans, study manuals, and charters.
  • Collaborate closely with the Clinical Development Lead on protocol development, amendments, and master ICFs.
  • Direct and manage CRO and vendor partnerships, holding them accountable for timelines, quality, and budget commitments.
  • Drive management of CROs, vendors, and external partners through oversight, escalation, and proactive issue resolution.
  • Oversee and coordinate the review of protocol deviations; manage amendments with cross-functional alignment.
  • Partner with Data Management to develop and approve data cleaning plans.
  • Contribute to inspection readiness and support audits and regulatory inspections.

Requirements

  • escalate issues proactively and implement CAPAs when required.

Compensation

  • $166,000 - $216,000 USD
  • Minimum of BA/BS with approximately 8+ years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs. Advanced degree preferred.
  • Experience within the field of cardiovascular studies and/or rare disease is desirable.
  • Experience in early and late phase drug development; some late-stage development experience is required.
  • Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
  • Excellent communication skills, both verbal and written

Benefits

  • Coordinate responses to health authorities, ethics committees, and IRBs as needed.

Company info

  • Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.
  • It is Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
  • Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
  • We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
  • At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals.
  • Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else.
  • We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit.
  • Lastly, we strive to enable the impossible because patients are counting on us.
  • We are not afraid to take risks to unlock innovation and advance scientific discoveries.
  • Kardigan is seeking a Sr.
  • Manager, Clinical Trial Lead to manage one of its cardiovascular clinical studies.
  • As a Clinical Trial Lead (CTL), you will be part of the Clinical Operations team reporting to the asset's Clinical Operations Program Leader (COPL).
  • The CTL may lead trials at a global level (overseeing multi-regional execution) or at a regional level (driving operational delivery in assigned countries/territories), depending on business needs.
  • This role is for a regional CTL.
  • As a regional CTL, you will ensure that key project deliverables are met according to the budget and timelines and quality standards (as defined by regulations, SOPs, and ICH-GCP) with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.
  • This position is 4-day onsite position in Princeton, NJ. (May consider onsite in South San Francisco)
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This listing is sourced directly from Kardigan's careers page and normalized into a canonical job model.